Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices 88083 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2023–27972 Filed 12–19–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5020] 

Notice to Public of Website Location of 

the Office of the Chief Scientist 

Proposed Guidance Development List 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the website location where 

the Agency will post a list of possible 

topics for future guidance document 

development or revision by the Office of 

the Chief Scientist (OCS) during the 

next year. In addition, FDA has 

established a docket where interested 

persons may provide comments that 

could benefit the OCS guidance program 

and its engagement with stakeholders, 

including comments on the priority of 

topics for guidance. This feedback is 

critical to the OCS guidance program as 

we consider feedback from stakeholders 

along with Agency resources and 

priorities. 

ADDRESSES: You may submit either 

electronic or written comments at any 

time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–5020 for ‘‘Notice to Public of 

Website Location of OCS Proposed 

Guidance Development Agenda.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Ross, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4332, Silver Spring, 

MD 20993–0002, 301–796–4880 (this is 

not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA welcomes comments on any or 

all of the topics for guidance documents 

on the list as explained in § 10.115(f)(5) 

(21 CFR 10.115(f)(5)). FDA has 

established Docket No. FDA–2023–N– 

5020 where comments on the list, drafts 

of proposed guidance documents on 

those or other topics, suggestions for 

new or different guidances within OCS’s 

purview, and relative priority of listed 

guidance documents may be submitted 

and shared with the public (see 

ADDRESSES). FDA believes this docket is 

a valuable tool for receiving information 

from interested persons. FDA 

anticipates that feedback from interested 

persons will allow OCS to better 

prioritize and more efficiently draft 

guidances to meet the needs of the 

Agency and our stakeholders. 

Consistent with the Good Guidance 

Practices regulation at § 10.115(f)(4), 

OCS would appreciate suggestions that 

OCS revise or withdraw an already 

existing guidance document within 

OCS’s purview. We request that the 

suggestion clearly explain why the 

guidance document should be revised or 

withdrawn and, if applicable, how it 

should be revised. 

II. Website Location of Guidance List 

This notice announces the website 

location of the document that provides 


ddrumheller on DSK120RN23PROD with NOTICES1
88084 Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices 

the list of possible topics for future 

guidance document development or 

revision by OCS during the next year. 

The initial list covers calendar year (CY) 

2024. To access the list, visit FDA’s 

website at https://www.fda.gov/aboutfda/guidance-documents-office-chiefscientist/office-chief-scientist-guidancedocuments-under-development. We 

note that the topics on this list may be 

removed or modified based on current 

priorities, as well as comments received 

regarding this list. Furthermore, several 

factors may impact FDA’s ability to 

issue a guidance, including, for 

example, new Administration priorities, 

emerging public health issues, or other 

extenuating circumstances. The Agency 

is not required to publish every 

guidance on the list if, for example, the 

resources needed would be to the 

detriment of meeting other Agency 

priorities and statutory obligations. In 

addition, the Agency is not precluded 

from issuing guidance documents that 

are not on the list. 

Dated: December 15, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27967 Filed 12–19–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Implement 

Maternal, Infant, and Early Childhood 

Home Visiting Program 2022 

Legislative Changes: Assessment of 

Administrative Burden 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 20, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Implement Maternal, Infant, and Early 

Childhood Home Visiting Program 2022 

Legislative Changes: Assessment of 

Administrative Burden, OMB No. 0906– 

xxxx—[New]. 

Abstract: The Consolidated 

Appropriations Act, 2023, Public Law 

117–328, Section 6101, the Jackie 

Walorski Maternal and Child Home 

Visiting Reauthorization Act of 2022 

(Section 6101 of the Consolidated 

Appropriations Act, 2023) extended 

funding for the Maternal, Infant, and 

Early Childhood Home Visiting 

(MIECHV) Program for an additional 5 

years and adopted new program 

requirements. This included a new 

requirement for the Secretary of Health 

and Human Services to assess and 

reduce burden on MIECHV funding 

recipients in administering the program 

by (1) eliminating duplication and 

streamlining reporting requirements; (2) 

analyzing ways, in consultation with 

administering agencies (i.e., MIECHV 

funding recipients) to reduce the 

number of hours spent on complying 

with paperwork requirements by at least 

15 percent; (3) reviewing paperwork and 

data collection requirements for tribal 

MIECHV funding recipients and 

exploring, in consultation with tribes 

and tribal organizations, ways to reduce 

administrative burden, respect 

sovereignty, and acknowledge the 

different focus points for tribal funding 

recipients; (4) collecting input from 

relevant state fiscal officials to align 

fiscal requirements and oversight for 

states and eligible entities to ensure 

consistency with standards and 

guidelines for other federal formula 

grant programs; and (5) consulting with 

administering agencies and service 

delivery model representatives on 

needed and unneeded data elements 

regarding the dashboards provided for 

in newly added Social Security Act 

subsection 511(d)(1)(B), consistent with 

the data requirements of such 

subsection. 

Through this ICR, HRSA aims to 

survey state, jurisdiction, and tribal 

MIECHV funding recipients to obtain 

feedback regarding potential ways to 

reduce administrative burden, as 

described above. Home visiting model 

developers will also be surveyed on 

potential ways to reduce administrative 

burden in their work to refine data 

collection requirements that align with 

MIECHV Program requirements. 

Need and Proposed Use of the 

Information: Section 511(h)(6)(A) of the 

Social Security Act requires the 

Secretary of Health and Human Services 

to assess and reduce administrative 

burden on MIECHV funding recipients. 

Information gained from this 

information collection will inform 

recommendations to reduce 

administrative burden. 

Likely Respondents: State and 

jurisdiction MIECHV Program funding 

recipients that are states, territories, 

and, where applicable, nonprofit 

organizations receiving MIECHV 

funding to provide home visiting 

services within states; tribal MIECHV 

Program funding recipients that are 

tribes and tribal organizations; and 

developers of home visiting models that 

are eligible for MIECHV funding. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


ddrumheller on DSK120RN23PROD with NOTICES1